Trial · NCT06290713
Vasodilator and Exercise Study for DMD (VASO-REx)
NCT06290713, Phase 2, Recruiting, University of Florida
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vasodilator and Exercise Study for DMD (VASO-REx). Trials, record NCT06290713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06290713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vasodilator and Exercise Study for DMD (VASO-REx)
- NCT number
- NCT06290713
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- University of Florida
- Conditions
- Duchenne Muscular Dystrophy, Duchenne Disease, Muscular Dystrophy, Muscular Dystrophy in Children, Vasodilation, Exercise, DMD
- Interventions
- Tadalafil, Placebo, Exercise Training
- First posted
- 2024-03-04
- Last updated
- 2026-05-15
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vascular responsiveness after muscle contraction to a single dose of tadalafil. | up to 4 weeks after the completion of Visits 1 and 2 of Aim 1. | Responsiveness will be determined by an increase in post-contractile muscle oxygenation using MRI-Blood Oxygen Level Dependent (BOLD) responses after dosing compared to before. Study participants demonstrating an increase (\>50%) in post-contractile BOLD after tadalafil will be enrolled into Aim 2 of this study. |
| Primary | Cycling time to fatigue | Baseline and 6 month follow-up visits of Aim 2. | The study will assess the impact of tadalafil on exercise performance and fatigue resistance compared to placebo. Participants will undergo a maximal effort cycling test before and after the intervention period. The time it takes for participants to reach exhaustion (TTE) will be recorded as the primary outcome measure. Measurement: Time to exhaustion (TTE) during a maximal effort cycling test on a recumbent, stationary ergometer. This test will quantify fatigue resistance by measuring the duration participants can sustain maximal effort cycling. |
| Secondary | Quadriceps muscle Fat Fraction | Aim 1 and Aim 2 (baseline and 6 month follow-up) | This outcome serves as a measure of disease severity. This measure is a sensitive and reproducible biomarker of DMD muscle pathology. |
| Secondary | Metabolic recovery | Through study completion, an average of 3 years. | The rate of phosphocreatine resynthesis after leg exercise will be quantified and serves as index of skeletal muscle mitochondrial oxidative capacity. (Part of Aim 2 of the study). |
| Secondary | cardiopulmonary exercise testing (CPET) - Peak aerobic capacity (VO2max) | Through study completion, an average of 3 years. | Patients will undergo cycling exercise at submaximal and peak workloads to quantify peak aerobic capacity, ventilation. Peak Oxygen Uptake (VO2max): This measure quantifies the maximum amount of oxygen the body can utilize during exercise, assessed through maximal cycling effort in a CPET. It serves as a primary indicator of overall cardiovascular and aerobic fitness. Peak aerobic capacity: VO2max reflects the maximum oxygen utilization capacity, indicating overall cardiovascular fitness. |
| Secondary | cardiopulmonary exercise testing (CPET) - Minute Ventilation (VE) | Through study completion, an average of 3 years. | Minute Ventilation (VE): This measure reflects the total volume of air breathed per minute during exercise, assessed throughout the CPET. Evaluating VE at various workloads provides insights into respiratory efficiency and potential limitations during exercise. Respiratory efficiency: VE and VE/VO2 assess how well the body utilizes oxygen during exercise, revealing potential respiratory limitations. |
| Secondary | cardiopulmonary exercise testing (CPET) - Ventilatory Equivalent for Oxygen (VE/VO2) | Through study completion, an average of 3 years. | Ventilatory Equivalent for Oxygen (VE/VO2): This ratio compares ventilation to oxygen uptake, calculated throughout the CPET. It indicates the efficiency of oxygen utilization during exercise and potential respiratory limitations. Respiratory efficiency: VE and VE/VO2 assess how well the body utilizes oxygen during exercise, revealing potential respiratory limitations. |
| Secondary | cardiopulmonary exercise testing (CPET) - Gas Exchange Threshold (GET) | Through study completion, an average of 3 years. | Gas Exchange Threshold (GET): This point during exercise marks the transition from predominantly aerobic to anaerobic metabolism, identified through changes in blood lactate levels and other CPET parameters. Analyzing GET helps assess exercise tolerance and potential for improvement. Exercise tolerance and fatigue: GET and W at AT pinpoint the intensity at which fatigue and performance decline become significant, offering insights into exercise limitations and potential for improvement. |
| Secondary | cardiopulmonary exercise testing (CPET) - Workload at Anaerobic Threshold (W at AT) | Through study completion, an average of 3 years. | Workload at Anaerobic Threshold (W at AT): This measure, derived from the CPET, quantifies the power output at which anaerobic metabolism significantly contributes to energy production. It reflects exercise intensity at which fatigue and performance decline become prominent. Exercise tolerance and fatigue: GET and W at AT pinpoint the intensity at which fatigue and performance decline become significant, offering insights into exercise limitations and potential for improvement. |
| Secondary | The 100-meter timed test (100m) | Through study completion, an average of 3 years. | The 100m is a fixed distance test of maximal performance and will be completed according to published guidelines. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers65
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AR079755 | Countering sympathetic vasoconstriction during skeletal muscle exercise as an adjuvant therapy for DMD | TAIVASSALO, TANJA | UNIVERSITY OF FLORIDA | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06290713
GET https://conductscience.org/api/trials/v1/NCT06290713/registered?page=2